Tenodesis screw system— 510(k) K151701

Substantially Equivalent

Normed Medizin-Technik GmbH

FDA 510(k) clearance K151701 for Tenodesis screw system, Substantially Equivalent on 2016-01-26. Applicant: Normed Medizin-Technik GmbH.

Clearance details

Applicant: Normed Medizin-Technik GmbH
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2015-06-24
Decision date: 2016-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.